The Effect of Low Level Light Therapy on Histamine- and Mucuna Pruriens-induced Pruritus in Healthy Volunteers

NCT05369338 | Completed DMC

• 1 other identifier: 33-431 ex 21/22
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

Brief Summary

This is a prospective, double-blind, randomised, sham-controlled study whose primary aim is to test whether LLLT changes the intensity of itch after histamine application in healthy volunteers compared to sham application.

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

• Pruritus Intensity

  Histaminergic itch is determined using a visual analogue scale (0-100) The non-histaminergic itch is determined by means of a visual analogue scale (0-100).

  2 minutes

Secondary Outcomes (3)

• Neurogenic inflammation

  10 minutes

• Alloknesia

  10 minutes

• Hyperknesia

  10 minutes

Study Arms (2)

Low Level Light Therapy

EXPERIMENTAL

The application of LLL is applied for 12 minutes using Repuls 7 (Repuls Lichtmedizintechnik GmbH, Vienna). This is a class IIb medical device. It applies pulsed red light of a frequency of 640nm. The intensity is 175 mWcm-2, which corresponds to a power density of 4,100 mW. The pulse frequency is set to 2.5 hz. The device is positioned 7cm from the skin using a distance ring.

Device: Low Level Light Therapy

Sham controll

SHAM COMPARATOR

The application of LLL is applied for 12 minutes using Repuls 7 (Repuls Lichtmedizintechnik GmbH, Vienna). This is a class IIb medical device. It applies pulsed red light of a frequency of 640nm. The intensity is 175 mWcm-2, which corresponds to a power density of 4,100 mW. The pulse frequency is set to 2.5 hz. The device is positioned 7cm from the skin using a distance ring. The sham treatment is performed with the same device and the same distance ring without activating it.

Device: Sham Controll

Interventions

Low Level Light Therapy DEVICE

The application of LLL is applied for 12 minutes using Repuls 7 (Repuls Lichtmedizintechnik GmbH, Vienna). This is a class IIb medical device. It applies pulsed red light of a frequency of 640nm. The intensity is 175 mWcm-2, which corresponds to a power density of 4,100 mW. The pulse frequency is set to 2.5 hz. The device is positioned 7cm from the skin using a distance ring. The sham treatment is performed with the same device and the same distance ring without activating it.

Also known as: LLLT

Low Level Light Therapy

Sham Controll DEVICE

The application of LLL is applied for 12 minutes using Repuls 7 (Repuls Lichtmedizintechnik GmbH, Vienna). This is a class IIb medical device. It applies pulsed red light of a frequency of 640nm. The intensity is 175 mWcm-2, which corresponds to a power density of 4,100 mW. The pulse frequency is set to 2.5 hz. The device is positioned 7cm from the skin using a distance ring. The sham treatment is performed with the same device and the same distance ring without activating it.

Sham controll

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Written informed consent of the participant
• Healthy test persons aged 18-60
• For female volunteers, negative pregnancy test

You may not qualify if:

• known allergy or hypersensitivity to histamine or the Mucuna pruriens
• history of skin diseases
• tattoos in the test area
• neoplasia in the test area
• pacemaker
• pregnancy
• epilepsy
• piercings
• fever
• local acute infection, skin inflammation/rashes

Sponsors & Collaborators

• Medical University of Graz: lead

Study Sites (1)

Medical university of Graz

Graz, 8010, Austria

Location

MeSH Terms

Interventions

Low-Level Light Therapy

Intervention Hierarchy (Ancestors)

Laser Therapy; Therapeutics; Phototherapy

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The subjects are blinded to the irradiation side by audiovisual masking (swimming goggles with blackened lenses, hearing protection). The subjects do not have access to the randomisation list and are not in the same room during the irradiation. This means that they are also blinded to the irradiation side.
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Model Details: Prospective, double-blind, randomised, sham-controlled

Study Record Dates

• First Submitted: May 6, 2022
• First Posted: May 11, 2022
• Study Start: May 6, 2022
• Primary Completion: August 4, 2022
• Study Completion: August 4, 2022
• Last Updated: August 15, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)